Clinical trial · Interventional
A Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer
A Randomized, Multicenter, Open-Label Cross-Over Study to Evaluate Participant and Healthcare Professional Reported Preference for Subcutaneous Atezolizumab Compared With Intravenous Atezolizumab Formulation in Participants With Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II, randomized, multi-center, multinational, open-label, cross-over study in adult participants with PD-L1-positive NSCLC. Two populations will be included: participants with resected Stage II, IIIA, and selected IIIB (T3-N2) NSCLC who have completed adjuvant platinum-based chemotherapy without evidence of disease relapse/recurrence, and chemotherapy-naïve participants with Stage IV NSCLC. The study will evaluate participant- and healthcare professionals (HCP)-reported preference for atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment A
- description
- Participants will receive atezolizumab SC followed by atezolizumab IV.
- interventionNames
- Drug: Atezolizumab
- type
- EXPERIMENTAL
- label
- Treatment B
- description
- Participants will receive atezolizumab IV followed by atezolizumab SC.
- interventionNames
- Drug: Atezolizumab
Primary outcomes (1)
- measure
- Percentage of Participants Who Preferred Atezolizumab SC to Atezolizumab IV Assessed Using Patient Preference Questionnaire (PPQ)
- timeFrame
- Cycle 6 Day 1 (cycle length=21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for All Participants: * ECOG performance status of 0 or 1 Inclusion Criteria for Participants with Early-stage NSCLC: * Participants must have a complete resection of a histologically or cytologically confirmed Stage II, IIIA, and selected IIIB (T3-N2) NSCLC * PD-L1 expression TC ≥ 1% or TPS ≥ 1% * Participants must have completed adjuvant chemotherapy at least 4 weeks and up to 12 weeks prior to randomization and must be adequately recovered from chemotherapy. For participants in the adjuvant setting, neoadjuvant chemotherapy or chemoradiotherapy is acceptable provided that participants also received adjuvant chemotherapy as per protocol's requirement. Inclusion Criteria for Participants with Stage IV NSCLC: * Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC * Life expectancy ≥ 18 weeks in the opinion of the investigator * PD-L1 expression TC ≥ 50% or TPS ≥ 50% or TC3 or IC3 * No prior systemic treatment for Stage IV non-squamous or squamous NSCLC * Participants who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment-free interval of at least 6 months from randomization since the last chemotherapy, radiotherapy, or chemoradiotherapy cycle. Exclusion Criteria for All Participants: * History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death * Uncontrolled tumor-related pain * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Participants known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene * History of leptomeningeal disease * Uncontrolled or symptomatic hypercalcemia * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina Exclusion Criteria for Participants with Stage IV NSCLC: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
References
Publications (2)
- DERIVEDBurotto M, Zvirbule Z, Alvarez R, Chewaskulyong B, Felip E, Majem M, Korbenfeld E, Kolb-Sielecki J, Isla D, Barata T, Bustillos A, Herraez-Baranda LA, Tosti N, Young F, Zanghi J, Cappuzzo F. Efficacy and safety of subcutaneous and intravenous administration of atezolizumab in patients with non-small cell lung cancer, including early-stage, locally advanced or metastatic disease: Updated results of the IMscin001 and IMscin002 randomized studies. Lung Cancer. 2026 Jul;217:109452. doi: 10.1016/j.lungcan.2026.109452. Epub 2026 May 12. PMID 42214243
- DERIVEDMajem M, Chewaskulyong B, Zvirbule Z, Lee KH, Korbenfeld E, Kolb-Sielecki J, Castro Sanchez AY, Bustillos A, Herraez-Baranda L, Liu X, Kim SW, Cappuzzo F. Exploratory Analyses of Patient Preferences for Atezolizumab Subcutaneous Versus Intravenous from the IMscin002 Study in Patients with Non-Small Cell Lung Cancer. Oncol Ther. 2026 Mar;14(1):313-326. doi: 10.1007/s40487-025-00402-x. Epub 2025 Nov 26. PMID 41296193